FDA recall Z-0205-2020

Siemens Healthcare Diagnostics, Inc. · Class II · device

Product

Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000

Reason for recall

Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2

Distribution

Nationwide Foreign: Argentina Australia Bangladesh Belgium Brazil Colombia Dominican Republic Finland France Germany Greece Italy Japan Latvia Mexico Netherlands P.R. China Republic Korea Singapore Spain Switzerland Thailand United Kingdom Vietnam

Key facts

Status: Terminated
Initiation date: 2019-08-15
Report date: 2019-10-30
Termination date: 2022-05-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tarrytown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0205-2020